Regulations 9, 11 and 14(e)
SCHEDULE 2ESSENTIAL COMPOSITION OF FOLLOW–ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER(All values refer to the product ready for use)
Energy
1.
Minimum | Maximum |
---|---|
250 kJ/100 ml | 335 kJ/100 ml |
(60 kcal/100 ml) | (80 kcal/100 ml) |
Proteins
2. (Protein content–nitrogen content × 6.38) for cows' milk proteins.
(Protein content–nitrogen content × 6.25) for soya protein isolates.
Minimum | Maximum |
---|---|
| |
0.5 g/100 kJ | 1 g/100 kJ |
(2.25 g/100 kcal) | (4.5 g/100 kcal) |
Lipids
3.
Minimum | Maximum |
---|---|
0.8 g/100 kJ | 1.5 g/100 kJ |
(3.3 g/100 kcal) | (6.5 g/100 kcal) |
(3.1) The use of the following substances is prohibited:
sesame seed oil;
cotton seed oil;
fats containing more than 8% trans isomers of fatty acids.
(3.2) Lauric acid
Minimum | Maximum |
---|---|
— | 15% of the total fat content |
(3.3) Myristic acid
Minimum | Maximum |
---|---|
— | 15% of the total fat content |
(3.4) Linoleic acid (in the form of glycerides=linoleates)
Minimum | Maximum |
---|---|
70 mg/100 kJ (300 mg/100 kcal): this limit applies only to follow-on formulae containing vegetable oils | — |
Carbohydrates
4.
Minimum | Maximum |
---|---|
1.7 g/100 kJ | 3.4 g/100 kJ |
(7 g/100 kcal) | (14 g/100 kcal) |
(4.1) The use of ingredients containing gluten is prohibited.
(4.2) Lactose
Minimum | Maximum |
---|---|
This provision does not apply to follow-on formulae in which soya protein isolates represent more than 50% of the total protein content. | |
0.45 g/100 kJ | — |
(1.8 g/100 kcal) | — |
(4.3) Sucrose, fructose, honey
Minimum | Maximum |
---|---|
— | separately or as a whole: 20% of the total carbohydrate content |
Mineral substances
per 100 kJ | per 100 kcal | ||||
---|---|---|---|---|---|
Minimum | Maximum | Minimum | Maximum | ||
Iron | (mg) | 0.25 | 0.5 | 1 | 2 |
Iodine | (μg) | 1.2 | — | 5 | — |
(5.2) Zinc
(5.2.1)Follow–on formulae manufactured entirely from cows' milk proteins
Minimum | Maximum |
---|---|
0.12 mg/100 kJ | — |
(0.5mg/100 kcal) | — |
(5.2.2)Follow–on formulae containing soya protein isolates, alone or mixed with cows' milk proteins
Minimum | Maximum |
---|---|
0.18 mg/100 kJ | — |
(0.75mg/100 kcal) | — |
(5.3) Other mineral substances:
The concentrations are at least equal to those normally found in cows' milk, reduced, where appropriate, in the same ratio as the protein concentration of the follow-on formulae to that of cows' milk. The typical composition of cows' milk is given, for guidance, in Schedule 7.
(5.4) The calcium/phosphorus ratio shall not exceed 2.0.
Vitamins
6.
per 100 kJ | per 100 kcal | ||||
---|---|---|---|---|---|
Minimum | Maximum | Minimum | Maximum | ||
Vitamin A | (μg–RE)(1) | 14 | 43 | 60 | 180 |
Vitamin D | (μg)(2) | 0.25 | 0.75 | 1 | 3 |
Vitamin C | (mg) | 1.9 | — | 8 | — |
Vitamin E | (mg*–TE)(3) | 0.5/g of | — | 0.5/g of | — |
polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0.1 mg per 100 available kJ | polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0.5 mg per 100 available kcal |
RE=all trans retinol equivalent.
In the form of cholecalciferol, of which 10 μg=400 i.u. of vitamin D.
*–TE=d–*–tocopherol equivalent.